Cinacalcet, effects on cardiovascular and bone health in chronic kidney disease (CKD)

Not Applicable

Completed

• Conditions: Patients with uncontrolled secondary hyperparathyroidism and who are on haemodialysis; Nutritional, Metabolic, Endocrine; Hyperparathyroidism and other disorders of parathyroid gland

• Registration Number: ISRCTN81718275
• Lead Sponsor: Salford Royal NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18-75 at recruitment, both male and female
2. On haemodialysis for >90 days
3. Parathyroid hormone (PTH) >=300 pg/ml
4. Corrected calcium >=2.1 mmol/l

Exclusion Criteria

1. Atrial fibrillation
2. Any contra-indications to magnetic resonance (MR) scan or ability to cooperate with scan
3. Any factors which will influence computed tomography (CT) scan e.g. artificial heart valves, previous sternotomy wires, stents
4. Contra-indication to cinacalcet e.g., pregnant, breast feeding, known reaction
5. Moderate to severe liver disease (alanine transaminase [ALT] >3x normal)
6. Have a poor record of compliance with medication
7. Have participated in a study involving an investigational drug during the 30 days prior to the first visit
8. Be involved in any other research study which exposes the patient to radiation above that of normal clinical practice

Study & Design

• Study Type: Interventional
• Study Design: Not specified